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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Chembio DPP® HIV 1/2 Assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 and 2 (HIV-1/2) in oral fluid, fingerstick whole blood, venous whole blood, serum, or plasma samples. The Chembio DPP HIV 1/2 Assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 20 individually pouched tests, 1 bottle of DPP HIV Running Buffer, 20 Sampletainer Bottles, 20 Oral Fluid Swabs, 20 Disposable Loops, 1 Product Insert, and 20 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
65-9500-0
In Commercial Distribution

  • 00607158000007 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
LIFECODES LifeScreen XP is a manual, qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules in patients sensitized to HLA by transfusion, pregnancy, or transplantation to aid donor and recipient match in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
628220
In Commercial Distribution

  • 10888234500841 ()
628220

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
ThromboType 1 assay is an assay for the molecular determination of HPA-1 (PlA) using PCR amplification of human genomic DNA.
IMMUCOR GTI DIAGNOSTICS, INC.
THROMBOTYPE1
In Commercial Distribution

  • 10888234500261 ()
THROMBOTYPE1

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
For Use with LIFECODES Class II IDv2
IMMUCOR GTI DIAGNOSTICS, INC.
403887
Not in Commercial Distribution

  • 10888234400622 ()
403887

  • HLA class II antigen tissue typing IVD, kit, multiplex
For Use with LIFECODES Class I ID
IMMUCOR GTI DIAGNOSTICS, INC.
628208
Not in Commercial Distribution

  • 10888234400585 ()
628208

  • HLA class I antigen tissue typing IVD, kit, multiplex
For Use with LIFECODES LifeScreen Deluxe
IMMUCOR GTI DIAGNOSTICS, INC.
628214
Not in Commercial Distribution

  • 10888234400547 ()
628214

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LIFECODES LSA Class II is a bead-based Immunoassay used to qualitatively detect HLA IgG antibodies to aid donor and recipient matching in transfusion or transplantation.
IMMUCOR GTI DIAGNOSTICS, INC.
265200IVD
In Commercial Distribution

  • 10888234400349 ()
265200IVD

  • HLA class II antigen tissue typing IVD, kit, multiplex
LIFECODES LifeScreen Deluxe is a qualitative bead-based immunoassay used to detect IgG antibodies to HLA Class I and Class II molecules
IMMUCOR GTI DIAGNOSTICS, INC.
628215
In Commercial Distribution

  • 10888234400318 ()
628215

  • HLA class I & II antigen tissue typing IVD, kit, multiplex
LIFECODES Class I ID is a bead-based immunoassay used to qualitatively detect Panel Reactive HLA IgG antibodies (PRA)
IMMUCOR GTI DIAGNOSTICS, INC.
628200
In Commercial Distribution

  • 10888234400295 ()
628200

  • HLA class I antigen tissue typing IVD, kit, multiplex
For Use with ThromboType1
IMMUCOR GTI DIAGNOSTICS, INC.
EGEL48
In Commercial Distribution

  • 10888234500667 ()
EGEL48

  • Multiple human platelet antigen (HPA) typing IVD, kit, multiplex
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